Catalog Number 955595 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Malaise (2359); Convulsion/Seizure (4406); Alteration in Body Temperature (4568)
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Event Date 01/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter phone no.:(b)(6).Facility name: (b)(6) medical university.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that during treatment with a prismaflex m100, a patient experienced symptoms similar to an allergic reaction further described as feeling discomfort, a rise in temperature, symptoms of convulsion and shortness of breath.It was reported the patient "gradually improved" after the treatment was stopped.No additional information is available.
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Manufacturer Narrative
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The actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the provided picture did not allow to identify any specific issue on the set.The reported condition was not verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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